MEDAZINES SYRUP
SCHEDULING STATUS:
S2
PROPRIETARY NAME
(and dosage form):
MEDAZINES SYRUP
COMPOSITION:
Each 5mL contains:
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Cyclizine HCl |
12,5mg |
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Preserved with: |
Methyl Hydroxybenzoate |
0,12% m/v |
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Propyl Hydroxybenzoate |
0,02% m/v |
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Contains 6% v/v Alcohol |
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PHARMACOLOGICAL CLASSIFICATION:
A5.7.2 Anti-emetics and antivertigo preparations.
PHARMACOLOGICAL ACTION:
MEDAZINE S syrup is a piperazine type antihistamine with antiemetic properties.
INDICATIONS:
The prevention and treatment of nausea and vomiting, particularly motion sickness and labyrinthine disorders (Meniere Syndrome).
CONTRA-INDICATIONS:
Individuals who have previously reacted adversely to cyclizine. Pregnancy
WARNINGS:
Drowsiness, dryness of mouth and blurred vision may occur and be aggravated by simultaneous intake of alcohol, and other central nervous system depressant agents. Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.
DOSAGE AND DIRECTIONS FOR USE:
To prevent motion sickness MEDAZINE S syrup should be taken about half an hour before the journey.
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Children 6to 12years |
10mL |
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Children 1to 5years |
5mL |
May be given three times daily.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Drowsiness, dryness of mouth and blurred vision may occur.
Other side-effects include inability to concentrate, lassitude, dizziness, hypotension, muscular weakness, inco-ordination, gastro-intestinal disturbances such as diarrhoea or constipation, epigastric pain, headache, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty with micturition, tightness of the chest and tingling, heaviness and weakness of the hand.
In children it may have the same effect as a central stimulant.
Blood disorders, including agranulocytosis and haemolytic anaemia, have been reported.
Patients are warned that MEDAZINE S syrup may enhance the sedative effect of central nervous depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquilizers. Since MEDAZINE S syrup has anticholinergic properties, it should be used with care in conditions liable to be exacerbated or otherwise adversely affected by atropine, such as glaucoma and prostatic hypertrophy. The side-effects of anticholinergic drugs such as atropine and tricyclic antidepressants may be enhanced by the concomitant administration of MEDAZINE S syrup.
MEDAZINE S syrup may affect the metabolism of drugs in the liver. MEDAZINE S may mask the warning symptoms of damage caused by ototoxic medicines.
Restlessness, dizziness and tachycardia may occur if atropine and MEDAZINE S syrup are used together.
Fixed drug eruptions, generalised chorea and hypersensitivity hepatitis have been reported.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of acute overdosage arise from effects of the preparation on the central nervous system and include drowsiness, dizziness, inco-ordination, weakness, convulsion, hyperpyrexia and respiratory depression. Agitation, ataxia and hallucinations may occur. Treatment is symptomatic and supportive.
IDENTIFICATION:
Clear yellow syrup with a naartjie flavour.
PRESENTATION:
Amber glass bottles containing 50mL, 100mL and 500mL.
STORAGE INSTRUCTIONS:
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:
A27/5.1.2/0204
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Medpro Pharmaceutica (Pty) Ltd
Unit 9 & 10
Rosen Heights Pasita Street
Rosen Park
BELVILLE
7530
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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